Normativa UEAbr. 18, 2013
UE: autoridad alimentaria revisa límites máximos de residuo para trifluralin
A decision not to include trifluralin in Annex I to Directive 91/414/EEC entered into force on 19 October 2007. EFSA is therefore required to provide a reasoned opinion on the review of the existing MRLs for that active substance in compliance with Article 12(1) of Regulation (EC) No 396/2005. Considering that the use of trifluralin is no longer authorised within the European Union and that no import tolerances were notified by the designated rapporteur Member State (Greece), EFSA based its assessment mainly on the conclusions derived by EFSA in the framework of Directive 91/414/EEC.
On 30 January 2013 EFSA issued a draft reasoned opinion that was circulated to Member States’ experts for consultation. No comments were received by 05 April 2013 and the following conclusions are derived.
The toxicological profile of trifluralin was evaluated in the framework of Directive 91/414/EEC, which resulted in an ADI being established at 0.015 mg/kg bw per d. An ARfD was not deemed necessary.
Considering that the use of trifluralin is no longer authorised within the EU, that no CXLs are available for this active substance and that no uses authorised in third countries were notified to the RMS, residues of trifluralin are not expected to occur in any plant commodity. Nevertheless, primary crop metabolism of trifluralin was investigated for two different crop groups (pulses and oilseeds and cereals). Parent trifluralin is extensively degraded in crop, giving place to several metabolites, all occurring at very low levels. None of the metabolites in edible commodities were considered to be relevant. Consequently, parent trifluralin is considered to be the only relevant residue for enforcement against a potential illegal use in plants. There are indications that parent trifluralin can be enforced with a LOQ of 0.01 mg/kg in dry, high oil content and high water content commodities.
Residues of trifluralin are also not expected to occur in livestock. Moreover, studies on the metabolism of trifluralin in lactating cow and laying hens demonstrated that negligible residues are present in the edible tissues, eggs and milk. No validated analytical methods for enforcement of residues in product of animal origin are available.
A risk assessment is in principle not required considering that the use of trifluralin is no longer authorised in the EU and that no import tolerances have been notified. Nevertheless, the reported LOQ value for plant commodities and the default MRL of 0.01 mg/kg for commodities of animal origin, as defined by Regulation (EC) No 396/2005, provide a satisfactory level of protection for the European consumer.
Based on the above assessment, the existing EU MRLs in plants commodities, exceeding the value 0.01 mg/kg are in principle no longer required. Considering however that the enforcement against potential illegal uses falls under the remit of risk managers, EFSA is not in a position to recommend whether the default MRL of 0.01 mg/kg, as defined by Regulation (EC) No 396/2005, should apply or whether the setting of a specific LOQ is necessary. Available data indicate that the default MRL of 0.01 mg/kg is sufficiently protective and could be enforced in practice, although this was only demonstrated in dry, high water content and high oil content commodities.